Abstract: The present invention relates to the field of pharmaceutical formulations of antibodies. Specifically, the present invention relates to a stable liquid antibody formulation and its pharmaceutical preparation and use. This invention is exemplified by an aqueous formulation of an anti-Tissue Factor Pathway Inhibitor (TFPI) antibody.

Abstract: The present invention provides compositions of Ig fusion proteins, especially compositions including an Ig fusion protein, a bulking agent, a disaccharide, a surfactant, and a buffer. In one aspect, these compositions are stable under long-term storage or at least one freeze/thaw cycle. The invention also provides methods of preparation of the Ig fusion protein compositions. In one aspect, compositions of the invention are lyophilized. In a further aspect, the compositions are lyophilized by a process that includes an annealing step.

Abstract: The present invention provides compositions of Ig fusion proteins, especially compositions including an Ig fusion protein, a bulking agent, a disaccharide, a surfactant, and a buffer. In one aspect, these compositions are stable under long-term storage or at least one freeze/thaw cycle. The invention also provides methods of preparation of the Ig fusion protein compositions. In one aspect, compositions of the invention are lyophilized. In a further aspect, the compositions are lyophilized by a process that includes an annealing step.

Abstract: The present invention provides improved methods to lyophilize (freeze-dry) active ingredients such as proteins, nucleic acids and viruses. The present methods improve the degree of excipient crystallization during lyophilization over prior methods. The improvement in excipient crystallization is based, in part, on a high-temperature annealing step is conducted prior to or at the same time as secondary drying. Importantly, the high-temperature annealing step does not destabilize active ingredients. Further, the high-temperature annealing step does not require sub-zero annealing steps prior to its enactment in order to provide complete excipient crystallization.